Infrared Images for Spinal Cord Stimulation in Complex Regional Pain Syndrome Patients

NCT05777889 | Recruiting

• 1 other identifier: 2022-2480
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare thermal camera Forward Looking InfraRed (FLIR) images before and after spinal cord stimulation to evaluate the difference in sympathetic activity of the affected limb in patients with complex regional pain syndrome (CRPS). The main questions it aims to answer are: Question 1: Can Infrared (FLIR) imaging be used to monitor the sympatholytic activity caused by Spinal Cord Stimulation (SCS) in patients with CRPS? Question 2: Is there any correlation between the quantification of sympatholytic activity produced by Spinal Cord Stimulation (SCS) and measured by FLIR imaging with the outcome measures in patients with CRPS? Outcome measures include pain (NRS), CRPS Severity Score (CSS), and neuropathic pain score (painDETECT). Participants will have an image of their feet taken perpendicularly with a 1-inch space from all four sides using a FLIR T420 or T62101 camera with 320\*240 resolution. Participants will also complete questionnaires about the average pain, CRPS severity, and neuropathic pain.

Conditions

Complex Regional Pain Syndromes

Keywords

spinal; infrared

Outcome Measures

Primary Outcomes (1)

• Temperature difference in limb

  The temperature of the limb will be measured using the forward-looking infrared camera. A 30% or more improvement in temperature difference in the affected limb 2-8 days after spinal cord stimulation will mean there was improvement.

  2-8 days after the trial procedure

Secondary Outcomes (3)

• Average Numerical Rating Scale (NRS) Pain

  2-8 days after the trial procedure

• Complex Regional Pain Syndrome Severity Score (CSS)

  2-8 days after the trial procedure

• Average level of Neuropathic Pain Score (PainDetect-PD)

  2-8 days after the trial procedure

Study Arms (1)

Study CRPS Group

Enrolled patients with complex regional pain syndrome undergoing a surgical procedure that requires spinal cord stimulation. All participants in the group will have an image of their feet taken perpendicularly with a 1-inch space from all four sides using a FLIR T420 or T62101 camera with 320\*240 resolution. All participants will also answer questionnaires about: their average pain score, CRPS severity, and neuropathic pain.

Other: Forward Looking InfraRed Camera

Interventions

Forward Looking InfraRed Camera OTHER

Forward Looking InfraRed Camera: 1. We will use a FLIR T420 or T62101 camera with a resolution of 320\*240. 2. Each image will be captured perpendicularly with a 1-inch gap on all four sides. 3. A Myler blanket placed in the background will separate the feet from the background. 4. The camera will be normalized to a temperature range of 15°C to 40°C. 5. The images will be saved in radiometric JPEG format. 6. Once the images have been transferred to a computer, we will remove the background. 7. Next, we'll make a temperature histogram with 0.1°C temperature bin resolution. 8. The before and after histograms (IB, IA) will be compared to see which one indicates more extreme temperature distributions. 9. Those who improve by 30% or more are considered to have had a successful spinal cord stimulation.

Study CRPS Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosised with complex regional pain syndrome, undergoing a surgery that requires spinal cord stimulation.

You may qualify if:

• The patient is between 18 and 85 years old
• Providing CRPS diagnostic criteria by using the Budapest Clinical Diagnostic Criteria.
• CRPS affecting unilateral lower extremity
• The patient has had pain and other symptoms for more than 3 months
• Not responding to conventional medical treatments and multidisciplinary approach
• High NRS detection in pain assessment despite appropriate treatment (NRS= and \> 6/10).
• Pain causing a limitation in the patient's functional capacity despite appropriate treatment.

You may not qualify if:

• Patients with suspected disc herniation, spinal stenosis, myelopathy, and suspected radiculopathy in detailed examinations and examinations (MRI, CT).
• Systemic or local infection
• Coagulation disorders
• History of allergy to contrast material
• Malignancy
• Pregnancy
• Uncontrollable medical and psychiatric condition
• The patients diagnosed with dysautonomia, sympathetic dysfunction other than CRPS (such as Raynaud disease or Buerger disease), sweating disorders other than CRPS (such as acquired idiopathic generalized anhidrosis), and patients

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Related Publications (8)

• Harden RN, McCabe CS, Goebel A, Massey M, Suvar T, Grieve S, Bruehl S. Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition. Pain Med. 2022 Jun 10;23(Suppl 1):S1-S53. doi: 10.1093/pm/pnac046.

  PMID: 35687369 RESULT

• Baron R, Schattschneider J, Binder A, Siebrecht D, Wasner G. Relation between sympathetic vasoconstrictor activity and pain and hyperalgesia in complex regional pain syndromes: a case-control study. Lancet. 2002 May 11;359(9318):1655-60. doi: 10.1016/S0140-6736(02)08589-6.

  PMID: 12020526 RESULT

• Croom JE, Foreman RD, Chandler MJ, Barron KW. Cutaneous vasodilation during dorsal column stimulation is mediated by dorsal roots and CGRP. Am J Physiol. 1997 Feb;272(2 Pt 2):H950-7. doi: 10.1152/ajpheart.1997.272.2.H950.

  PMID: 9124459 RESULT

• Jacobs MJ, Jorning PJ, Joshi SR, Kitslaar PJ, Slaaf DW, Reneman RS. Epidural spinal cord electrical stimulation improves microvascular blood flow in severe limb ischemia. Ann Surg. 1988 Feb;207(2):179-83. doi: 10.1097/00000658-198802000-00011.

  PMID: 3257679 RESULT

• Linderoth B, Fedorcsak I, Meyerson BA. Peripheral vasodilatation after spinal cord stimulation: animal studies of putative effector mechanisms. Neurosurgery. 1991 Feb;28(2):187-95.

  PMID: 1671794 RESULT

• Huh BK, Park CH, Ranson M, Campbell GL, Ravanbakht J. Thermogram in spinal cord stimulation with complex regional pain syndrome and a review of the literature. Neuromodulation. 2010 Apr;13(2):114-6. doi: 10.1111/j.1525-1403.2009.00236.x. Epub 2009 Sep 3.

  PMID: 21992784 RESULT

• Harden RN, Bruehl S, Stanton-Hicks M, Wilson PR. Proposed new diagnostic criteria for complex regional pain syndrome. Pain Med. 2007 May-Jun;8(4):326-31. doi: 10.1111/j.1526-4637.2006.00169.x.

  PMID: 17610454 RESULT

• Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Schlereth T, Chont M, Vatine JJ. Development of a severity score for CRPS. Pain. 2010 Dec;151(3):870-876. doi: 10.1016/j.pain.2010.09.031. Epub 2010 Oct 20.

  PMID: 20965657 RESULT

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Semih Gungor, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pa Thor, PhD

CONTACT

646-797-8535; thorp@hss.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 21, 2023
• Study Start: February 22, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: For researchers who provide a methodologically sound proposal and analyses to achieve aims in the approved proposal. Proposals should be directed to siderisa@hss.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)